Post Market Study to Collect Data for Software Recognizing the Anatomical Structures During Bronchoscopy.

NCT04770675 | Completed

• 1 other identifier: CIS-20
• Study Type: observational
• Target: 833
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure and using existing bronchoscopy technology.

Conditions

Tumor; Hemoptysis; Pulmonary Disease

Keywords

bronchoscope

Outcome Measures

Primary Outcomes (1)

• Number of anatomical segments accessed during bronchoscopy

  accurate photo documentation of all 18 anatomical segments +/- abnormalities

  1 day

Secondary Outcomes (3)

• Number of anatomical segments identified

  1 day

• Rate of total number of lesions detected

  1 day

• Number of sections and lesions detected by core lab and machine learning

  1 day

Study Arms (1)

Treatment group

Any subject who is scheduled to undergo bronchoscopy as per routine clinical practice

Diagnostic Test: Bronchoscopy

Interventions

Bronchoscopy DIAGNOSTIC_TEST

All subjects who are scheduled for a bronchoscopy may be eligible.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The bronchoscope is used to confirm or exclude a diagnosis in adult patients with airway complaints to identify a potential disease.

You may qualify if:

• Oral and written participant information has been given (NA for Denmark)
• The subject has signed informed consent (NA for Denmark)
• Patients indicated for full airway bronchoscopy (identifying all 18 anatomical segments)
• Patients older than 18

You may not qualify if:

• Subject with serious lung disease which investigator considers not appropriate for this examination.
• Lack of patient cooperation for bronchoscopy (patient with mental disorders, dysgnosia, psychological disorder…)
• Subjects unable to give consent (NA for Denmark)

Sponsors & Collaborators

• Qmed Consulting A/S: lead
• Ambu A/S: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Hemoptysis; Lung Diseases

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Michael Perch, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 25, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2 years after study end
• Access Criteria: restricted access with user accounts to electronic data capture system

Locations

DK (1)